Bowed runners and corresponding valve assemblies for paravalvular leak protection

ABSTRACT

A prosthetic heart valve for replacing a native valve includes a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition. At least one runner is coupled a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.

BACKGROUND OF THE INVENTION

The present disclosure relates in general to heart valve replacementand, in particular, to collapsible prosthetic heart valves. Moreparticularly, the present disclosure relates to devices and methods forpositioning and sealing collapsible prosthetic heart valves within anative valve annulus,

Prosthetic heart valves that are collapsible to a relatively smallcircumferential size can be delivered into a patient less invasivelythan valves that are not collapsible. For example, a collapsible valvemay be delivered into a patient via a tube-like delivery apparatus suchas a catheter, a trocar, a laparoscopic instrument, or the like. Thiscollapsibility can avoid the need for a more invasive procedure such asfull open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valvestructure mounted on a stent. There are two common types of stents onwhich the valve structures are mounted: a self-expanding scent or aballoon-expandable stent. To place such valves into a delivery apparatusand ultimately into a patient, the valve must first be collapsed orcrimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant sitein the patient (e.g., at or near the annulus of the patient's heartvalve that is to be replaced by the prosthetic valve), the prostheticvalve can be deployed or released from the delivery apparatus andre-expanded to full operating size. For balloon-expandable valves, thisgenerally involves releasing the entire valve, and then expanding aballoon positioned within the valve stent. For self-expanding valves, onthe other hand, the stent automatically expands as the sheath coveringthe valve is withdrawn.

SUMMARY OF THE INVENTION

In some embodiments, a prosthetic heart valve for replacing a nativevalve includes a stent extending between a proximal end and a distal endand including a plurality of struts forming cells, the stent having acollapsed condition and an expanded condition. At least one runner iscoupled to a cell, the at least one runner being configured totransition from a first configuration to a second configuration when thestent moves from the collapsed condition to the expanded condition, theat least one runner projecting radially outwardly from the cell in thesecond configuration. A valve assembly is disposed within the stent, thevalve assembly including a plurality of leaflets, a cuff at leastpartially disposed on a luminal surface of the stent and a coveringmaterial disposed on an abluminal surface of the stent and covering theat least one runner in the second configuration.

In some embodiments, a prosthetic heart valve for replacing a nativevalve includes a stent extending between a proximal end and a distal endand including a plurality of struts forming cells and a plurality ofrunners, the stent having a collapsed condition and an expandedcondition, the struts defining a first diameter and the runners defininga second diameter, the second diameter being greater than the firstdiameter. A valve assembly is disposed within the stent, the valveassembly including a plurality of leaflets and a cuff at least partiallydisposed on a luminal surface of the stent and partially disposed on anabluminal surface of the stent to cover the runner.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments in accordance with the present disclosure will nowbe described with reference to the appended drawings. It is to beappreciated that these drawings depict only some embodiments and aretherefore not to be considered limiting of its scope.

FIG. 1 is a side elevational view of a conventional prosthetic heartvalve;

FIG. 2 is a highly schematic cross-sectional view taken along line A-Aof FIG. 1 and showing the prosthetic heart valve disposed within anative valve annulus;

FIG. 3A is a highly schematic aide view of one embodiment of a heartvalve having bowed runners intended to fill irregularities between theheart valve and the native valve annulus;

FIG. 3E is a developed view of the stent of the heart valve of FIG. 3Ain the collapsed configuration;

FIGS. 3C and 3D are enlarged highly schematic partial views of a stentcell having a runner in the collapsed configuration and bowedconfiguration, respectively;

FIGS. 4A-D are highly schematic side views of one method of deliveringand deploying the heart valve of FIG. 3A within the native valveannulus;

FIGS. 5A-10B are enlarged highly schematic partial side views of severalvariations of collapsed stent cells having runners and their respectiveshapes in the bowed configuration;

FIGS. 11A-C are enlarged highly schematic side views of heart valveshaving bowed runners at various longitudinal positions; and

FIG. 12 is a highly schematic cross-sectional view of a heart valvehaving bowed runners disposed within a native valve annulus;

FIGS. 13-15 are highly schematic developed views of portions of heartvalves including cuffs having folding flaps for covering runners in afirst row;

FIGS. 16A and 16B are highly schematic partial views of another methodof folding a cuff over runners in a first row;

FIG. 17 is a highly schematic developed view of a portion of a heartvalve having a cuff and individual panels attached over runners in afirst row;

FIGS. 18-20 are highly schematic developed views of portions of heartvalves including cuffs having folding flaps attached over runners in asecond row;

FIG. 21 is a highly schematic developed view of a portion of a heartvalve including a cuff and a covering disposed over runners in a secondrow; and

FIGS. 22A-24 are highly schematic developed views of portions of heartvalves including cuffs having various folding flaps and panels forcovering runners in a third row.

DETAILED DESCRIPTION

Despite various improvements that have been made to the collapsibleprosthetic heart valve delivery process, conventional devices sufferfrom some shortcomings. For example, with conventional self-expandingvalves, the clinical success of the valve is dependent on accuratedeployment and anchoring. Inaccurate deployment and anchoring of thevalve increases risks, such as those associated with valve migration,which may cause complications due to the obstruction of the leftventricular outflow tract. Inaccurate deployment and anchoring may alsoresult in the leakage of blood between the implanted heart valve and thenative valve annulus, commonly referred to as paravalvular leakage (alsoknown as “perivalvular leakage”). In aortic valves, this leakage enablesblood to flow from the aorta back into the left ventricle, reducingcardiac efficiency and putting a greater strain on the heart muscle.Additionally, calcification of the aortic valve may affect performanceand the interaction between the implanted valve and the calcified tissueis believed to be relevant to leakage, as will be outlined below.

Moreover, anatomical variations from one patient to another may cause afully deployed heart valve to function improperly, requiring removal ofthe valve from the patient or performing an additional valve-in-valveprocedure. Removing a fully deployed heart valve increases the length ofthe procedure as well as risks. Thus, methods and devices are desirablethat would reduce the need to remove a prosthetic heart valve from apatient. Methods and devices are also desirable that would reduce thelikelihood of paravalvular leakage due to gaps between the implantedheart valve and patient tissue.

There therefore is a need for further improvements to the devices,systems, and methods for positioning and sealing collapsible prostheticheart valves. Specifically, there is a need for further improvements tothe devices, systems, and methods for accurately implanting a prostheticheart valve. Among other advantages, the present disclosure may addressone or more of these needs.

As used herein, the term “proximal,” when used in connection with aprosthetic heart valve, refers to the end of the heart valve closest tothe heart when the heart valve is implanted in a patient, whereas theterm. “distal,” when used in connection with a prosthetic heart valve,refers to the end of the heart valve farthest from the heart when theheart valve is implanted in a patient. When used in connection withdevices for delivering a prosthetic heart valve or other medical deviceinto a patient, the terms “trailing” and “leading” are to he taken asrelative to the user of the delivery devices. “Trailing ” is to beunderstood as relatively close to the user, and “leading” to beunderstood as relatively farther away from the user.

The sealing portions of the present disclosure may be used in connectionwith collapsible prosthetic heart valves. FIG. 1 shows one suchcollapsible stent-supported prosthetic heart valve 100 including a stent102 and a valve assembly 104 as is known in the art. Prosthetic heartvalve 100 is designed to replace a native tricuspid valve of a patient,such as a native aortic valve. It should be noted that while thedisclosures herein relate predominantly to prosthetic aortic valveshaving a stent with a shape as illustrated in FIG. 1, the valve could bea bicuspid valve, such as the mitral valve, and the stent could havedifferent shapes, such as flared or conical annulus section, aless-bulbous aortic section, and the like, and a differently shapedtransition section.

Prosthetic heart valve 100 will be described in more detail withreference to FIG. 1. Prosthetic heart valve 100 includes expandablestent 102 which may be formed from biocompatible materials that arecapable of self-expansion, such as, for example, shape memory alloys,such as the nickel-titanium alloy known as “Nitinol” or other suitablemetals or polymers. Stent 102 extends from proximal or annulus end 130to distal or aortic end 132, and includes annulus section 140 adjacentproximal end 130, transition section 141 and aortic section 112 adjacentdistal end 132. Annulus section 140 may have a relatively smallcross-section in the expanded configuration, while aortic section 142may have a relatively large cross-section in the expanded configuration.Preferably, annulus section 140 is in the form of a cylinder having asubstantially constant diameter along its length. Transition section 141may taper outwardly from annulus section 140 to aortic section 142. Eachof the sections of stent 102 includes a plurality of struts 160 formingcells 162 connected to one another in one or more annular rows aroundthe stent. For example, as shown in FIG. 1, annulus section 140 may havetwo annular rows of complete cells 162 and aortic section 142 andtransition section 141 may each have one or more annular rows of partialcells 162. Cells 162 in aortic section 142 may be larger than cells 162in annulus section 140. The larger cells in aortic section 142 betterenable prosthetic valve 100 to be positioned. In the native valveannulus without the stent structure interfering with blood flow to thecoronary arteries.

Stent 102 may include one or more retaining elements 168 at distal end132 thereof, retaining elements 168 being sized and shaped to cooperatewith female retaining structures (not shown) provided on the deploymentdevice. The engagement of retaining elements 168 with the femaleretaining structures on the deployment device helps maintain prostheticheart valve 100 in assembled relationship with the deployment device,minimizes longitudinal movement of the prosthetic heart valve relativeto the deployment device during unsheathing or resheathing procedures,and helps prevent rotation of the prosthetic heart valve relative to thedeployment device as the deployment device is advanced to the targetlocation and the heart valve deployed.

Prosthetic heart valve 100 includes valve assembly 104 preferablysecured to stent 102 in annulus section 140. Valve assembly 104 includescuff 176 and a plurality of leaflets 178 which collectively function asa one-way valve by coapting with one another. As a prosthetic aorticvalve, valve 100 has three leaflets 178. However, it will be appreciatedthat other prosthetic heart valves with which the sealing portions ofthe present disclosure may be used may have a greater or lesser numberof leaflets.

Although cuff 176 is shown in FIG. 1 as being disposed on the luminal orinner surface of annulus section 140, it is contemplated that cuff 176may be disposed on the abluminal or outer surface of annulus section 140or may cover all or part of either or both of the luminal and abluminalsurfaces. Both cuff 176 and leaflets 178 may be wholly or partly formedof any suitable biological material, or polymer such as, for example,Polyethylene terephthalate (PET), ultra-high-molecular-weightpolyethylene (UHMWPE), or polytetrafluoroethylene (PTFE).

Leaflets 178 may be attached along their belly portions to cells 162 ofstent 102, with the commissure between adjacent leaflets 178 attached tocommissure features 166. As can be seen in FIG. 1, each commissurefeature 166 may lie at the intersection of four cells 162, two of thecells being adjacent one another in the same annular row, and the othertwo cells being in different annular rows and lying in end-to-endrelationship. Preferably, commissure features 166 are positionedentirely within annulus section 140 or at the juncture of annulussection 140 and transition section 141. Commissure features 166 mayinclude one or more eyelets which facilitate the suturing of the leafletcommissure to stent 102.

Prosthetic heart valve 100 may be used to replace a native aortic valve,a surgical heart valve or a heart valve that has undergone a surgicalprocedure. Prosthetic heart valve 100 may be delivered to the desiredsite (e.g., near the native aortic annulus) using any suitable deliverydevice. During delivery, prosthetic heart valve 100 is disposed insidethe delivery device in the collapsed configuration. The delivery devicemay be introduced into a patient using a transfemoral, transaortic,transsubclavian, transapical, transseptal or any other percutaneousapproach. Once the delivery device has reached the target site, the usermay deploy prosthetic heart valve 100. Upon deployment, prosthetic heartvalve 100 expands so that annulus section 140 is in secure engagementwithin the native aortic annulus. When prosthetic heart valve 100 isproperly positioned inside the heart, it works as a one-way valve,allowing blood to flow from the left ventricle of the heart to theaorta, and preventing blood from flowing in the opposite direction.

FIG. 2 is a highly schematic cross-sectional illustration of prostheticheart valve 100 disposed within native valve annulus 250. As seen in thefigure, valve assembly 104 has a substantially circular cross-sectionwhich is disposed within the non-circular native valve annulus 250. Atcertain locations around the perimeter of heart valve 100, gaps 200 formbetween heart valve 100 and native valve annulus 250. Blood flowingthrough these gaps and past valve assembly 104 of prosthetic heart valve100 can cause regurgitation and other inefficiencies which reducecardiac performance. Such improper fitment may be due to suboptimalnative valve annulus geometry due, for example, to calcification ofnative valve annulus 250 or to unresected native leaflets.

FIG. 3A illustrates one embodiment of heart valve 300 intended to fillthe irregularities between the heart valve and native valve annulus 250shown in FIG. 2. Heart valve 300 extends between proximal end 302 anddistal end 304, and may generally include stent 306 and valve assembly308 having a plurality of leaflets 310 and cuff 312. Heart valve 300 maybe formed of any of the materials and in any of the configurationsdescribed above with reference to FIG. 1.

Stent 306 may include a plurality of struts 320. Certain struts 320 mayterminate in retaining elements 321 at distal end 304. Struts 320 maycome together to form cells 322 connected to one another in one or moreannular rows around the stent. Connected to struts 320 are a pluralityof runners 330, which are additional struts that bow or bulge outradially when stent 306 is expanded, as will be described in greaterdetail with reference to FIGS. 3B and 3C.

In order to better appreciate the attachment and placement of runners330, stent 306 is shown in FIG. 3B in its collapsed configuration. Forthe sake of clarity, valve assembly 308 is not shown in this figure. Inthe collapsed configuration of scent 306, each of cells 322 is alsocollapsed. Stent 306 extends from proximal or annulus end 302 of heartvalve 300 to distal or aortic end 304, and includes annulus section 340adjacent proximal end 302, aortic section 342 adjacent distal end 304,and transition section 341 between annulus section 340 and aorticsection 342. Commissure features 345 may be positioned entirely withinannulus section 340 or at the juncture of annulus section 340 andtransition section 341 as shown.

One or more cells 322 may include runners 330. An enlarged partial sideview of cell 322 including a runner 330 is shown in FIG. 3C. Four struts320 a, 320 b, 320 c, 320 d may join to form cell 322, each strut beingattached to two adjacent struts. In the collapsed configuration of stent306, cell 322 may be stadium-shaped as shown. In the expandedconfiguration of stent 306, cell 322 may shorten in the length directionof stent 306 between proximal end 302 and distal end 304, and struts 320may generally form a diamond shape (FIG. 3D).

Runners 330 may extend from first attachment end 335 a where struts 320a and 320 c meet to second attachment end 335 b where struts 320 b and320 d meet, and may be affixed to stent 306 by welding, adhesive, or anyother suitable technique known in the art. Moreover, instead of beingseparately formed and affixed to stent 306 at attachment ends 335 a, 335b, runners 330 may be integrally formed with stent 306, such as by lasercutting both stent 306 and runners 330 from the same tube. Additionally,runners 330 may be formed of a shape memory material such as thosedescribed above for forming stent 102 of FIG. 1, and may have asubstantially linear configuration in the collapsed configuration ofheart valve 300 (FIG. 3C) and a curved or bowed configuration in theexpanded configuration of heart valve 300 (FIG. 3D).

In the collapsed configuration, runner 330 may bisect cell 322 intofirst portion 360 a and second portion 360 b. As the length of cell 322shortens in the expanded configuration of heart valve 300, the unchangedlength of runner 330 causes the runner to bow or deflect outwardly ofthe curved surface defined by struts 320 a, 320 b, 320 c, 320 d. Stent306 may also be heat set such that struts 320 and runner 330 return to apredetermined shape in the fully expanded configuration (e.g., when noexternal forces are applied thereto). When cuff 312 (FIG. 3A) is coupledto the abluminal surface of annulus section 340 of stent 306, the cuffis substantially tubular when runners 330 are not bowed outwardly. Whenrunners 330 how outwardly on the expansion of heart valve 300, they formprotuberances in cuff 312 to help seal heart valve 300 within the nativevalve annulus.

A method of delivering and implanting heart valve 300 will now bedescribed with reference to FIGS. 4A-D. A delivery system 400 may beused to deliver and deploy heart valve 300 in native valve annulus 250,and may generally include sheath 410, shaft 420, atraumatic tip 430 andhub 440. Sheath 410 may be slidable relative to shaft 420. Heart valve300, including stent 306, valve assembly 308 and runners 330, may bedisposed within sheath 410 about shaft 420 (FIG. 4A). Hub 440 may becoupled to shaft 420 and configured to mate with retaining elements 321of heart valve 300. Runners 330 of heart valve 300 may be disposed inthe linear configuration of FIG. 30, substantially parallel to sheath410, during delivery. Specifically, though runners 330 are configured toreturn, to their curved configuration, they may be kept substantiallylinear by being constrained within sheath 410. By doing so, heart valve300 may be delivered to the native valve annulus using delivery system400 without increasing the radius of sheath 410, avoiding the need toincrease the crimp profile of the heart valve within delivery system400. A large delivery system may be incapable of being passed throughthe patient's vasculature, while a delivery system having a heart valvewith a smaller crimp profile may be easier to navigate through apatient's body and may also reduce the length of the implantationprocedure. In the example shown in FIGS. 4A-D, delivery system 400 isdelivered from the aorta toward the left ventricle as indicated by arrowS1. If heart valve 300 or delivery system 400 includes echogenicmaterials, such materials may be used to guide delivery system 400 tothe appropriate position using the assistance of three-dimensionalechocardiography to visualize heart valve 300 within the patient.Alternative visualization techniques known in the art are alsocontemplated herein.

When delivery system 400 has reached the proper location (e.g.,atraumatic tip 430 is lust past native valve annulus 250), atraumatictip 430 may be advanced slightly in the direction of arrow S1 toward theleft ventricle by pushing shaft 420 toward atraumatic tip 430 whileholding sheath 410 in place, which serves to decouple atraumatic tip 430from sheath 410 (FIG. 4B). Sheath 410 may then be retracted in thedirection of arrow S2 toward the aorta. With sheath 410 slightlyretracted, heart valve 300 begins to emerge from the sheath. As sheath410 is further retracted in the direction of arrow S2, more of heartvalve 300 is exposed until annulus section 340 is fully exposed andrunners 330 become bowed (FIG. 40). Thus, sheath 410 may be retracteduntil heart valve 300 is free to self-expand within native valve annulus250. While heart valve 300 is partially deployed (e.g., a portion ofheart valve 300 is outside sheath 410, but heart valve 300 is not fullydetached from delivery system 400), if it appears that heart valve 300needs to be recaptured and redeployed due to, for example, improperpositioning or orientation, sheath 410 may be slid over shaft 420 in thedirection of arrow S1 to recapture heart valve 300 within sheath 410.During recapture, sheath 410 may push against bowed runners 330 tostraighten them to the linear configuration shown in FIG. 30. Thisprocess may be repeated until heart valve 300 is properly positioned anddeployed within native valve annulus 250.

After sheath 410 has been fully retracted to expose heart valve 300,runners 330, now in their bowed or curved configuration, push cuff 312outwardly against native valve annulus 250 and occlude gaps 200 betweenheart valve 300 and native valve annulus 250, thereby reducing oreliminating the amount of blood that passes around heart valve 300through gaps 200 (FIG. 4D). Retaining elements 321 of heart valve 300may decouple from hub 440 as heart valve 300 fully expands, atraumatictip 430 may be retracted through heart valve 300 in the direction ofarrow 32 and delivery system 400 may be removed from the patient.

Several variations of runners are described with reference to FIGS.5A-10B. In each variation, a collapsed cell is shown along with aschematic of the cell in the expanded configuration. As used herein theterms expanded and collapsed may refer to the configurations of a cell,a stent, a heart valve and a valve assembly interchangeably.

FIG. 5A shows cell 522 of a stent having four struts 520 a, 520 b, 520c, 520 d, each strut being attached to two adjacent struts. In thecollapsed configuration of the stent, cell 522 may be stadium-shaped asshown (FIG. 5A). Runner 530 may extend between two attachment ends 535a, 535 b. Specifically, runner 530 may be joined to third strut 520 c atfirst attachment end 535 a and to diagonally-opposed second strut 520 bat second attachment end 539 b. Runner 530 may diagonally divide cell522 substantially equally into first portion 560 a and second portion560 b in the collapsed configuration. When cell 522 is placed in theexpanded configuration (FIG. 5B), the cell may form a substantiallydiamond shape, with runner 530 stretching diagonally from strut second520 b to third strut 520 c across the cell. Because attachment ends 535a, 535 b are closer to one another in the expanded configuration than inthe collapsed configuration, runner 530 may bow outwardly to form aprotuberance.

FIG. 6A shows cell 622 or a stent having four struts 620 a, 620 b, 620c, 620 d, each strut being attached to two adjacent struts. Runner 630may extend between two attachment ends 635 a, 635 b located at junctionsof two struts (e.g., attachment end 635 a is at the junction of struts620 a and 620 c, while attachment end 635 b is at the junction of struts620 b and 620 d) and bisect cell 622 into substantially equal firstportion 660 a and second portion 660 b in the collapsed configuration.Runner 630 may be tapered as shown, having a larger width at attachmentends 635 a, 635 b than at its middle. A tapered runner 630 may provideadded flexibility and may be easier to heat set so that it readilyreturns to the bowed configuration when cell 622 is expanded, as shownin FIG. 6B.

FIG, 7A shows cell 722 or a scent having tour struts 720 a, 720 b, 720c, 720 d, each strut being attached to two adjacent struts. Unlike cell322, runner 730 is joined to cell 722 at a single attachment end 735 aonly and is able to deflect at free end 735 b opposite attachment end735 a. It will be understood that the single point of attachment may bedisposed at any of struts 720 a, 720 b, 720 c, 720 d or at theintersection of any two struts (e.g., at the intersection of secondstrut 720 b and fourth strut 720 d as shown, or at the opposite end atthe intersection of first strut 720 a and third strut 720 c, or at theintersection of first strut 720 a and second strut 720 b, or third strut720 c and fourth strut 720 d). In the collapsed configuration, runner730 fills a portion of cell 722 so that a U-shaped cutout 760 a isformed within cell 722. In the expanded configuration (FIG. 7B), runner730 is capable of bowing radially outwardly to provide paravalvularsealing.

FIG. 8A shows cell 822 of a stent having four struts 820 a, 820 b, 820c, 820 d, each strut being attached to two adjacent struts. Cell 822includes a pair of runners 830 a, 830 b that are substantially parallelto one another in the collapsed configuration. First runner 830 a iscoupled to first strut 820 a at first attachment end 835 a and to secondstrut 820 b at second attachment end 835 b, while second runner 830 b iscoupled to third strut 820 c at third attachment end 835 c and, tofourth strut 820 d at fourth attachment end 835 d. Moreover, first andsecond runners 830 a, 830 b are coupled to one another at midpoint 845,which keeps runners 830 a, 830 b close together along a midline of thediamond shaped cell 822 in the expanded configuration (FIG. 8B). Twinrunners 830 a, 83ob may provide a larger support surface over which acuff may be stretched to better seal a heart valve within a native valveannulus.

FIG. 9A shows another variation having twin runners. Cell 922 includesfour struts 920 a, 920 b, 920 c, 920 d, each strut being attached to twoadjacent struts. Cell 922 includes a pair of runners 930 a, 930 b thatare substantially parallel to one another in a collapsed configuration.First runner 930 a is coupled to the junction of first strut 920 a andthird strut 920 c at first attachment end 935 a and to the junction ofsecond strut 920 b and third strut 920 d at second attachment end 935 b,while second runner 930 b is coupled to the same two junctions at thirdattachment end 935 c and fourth attachment end 935 d. Runners 930 a, 930b are not joined to one another except for having attachment ends nearone another. When cell 922 expands, runners 930 a, 930 b bow outwardlyand separate to provide scaffolding upon which a cuff may be stretched(FIG. 9B). Instead of the cuff being stretched out over a single bowedrunner or dual bowed runners attached at a midpoint, stretching the cuffover twin bowed runners that are spaced apart from one another providesa greater support area. Thus, this separation of bowed runners 930 a,930 b may provide a more uniform protuberance for better sealing of aheart valve within the native valve annulus.

Another variation, shown in FIG. 10A, includes cell 1022 having fourstruts 1020 a, 1020 b, 1020 c, 1020 d, each strut being attached to twoadjacent struts. Runner 1030 is formed as a U-shaped nested strut in thecollapsed configuration, being attached to two adjacent struts 1020 a,1020 c at attachment ends 1035 a, 1035 b, respectively. In the expandedconfiguration, runner 1030 bows radially outwardly to form aprotuberance (FIG. 10B). Because bowed runner 1030 is attached toadjacent struts 1020 a, 1020 c in the same half of cell 1022 andstretches between two attachment points at about the same longitudinalposition, in the expanded configuration, bowed runner 1030 extendslaterally across cell 1022.

Additionally, runners may be provided at a variety of locations on astent. For example, in FIG. 11A heart valve 1100A extends betweenproximal end 1102 and distal end 1104, and may generally include stent1106 and valve assembly 1108 having a plurality of leaflets 1110 andcuff 1112. Heart valve 1100A may be formed of any of the materials andin any of the configurations described above with reference to FIG. 1.

Stent 1106 may include a plurality of struts 1120, which may cometogether to form cells such as cell 1122A connected to one another inone or more annular rows around the stent. Connected to struts 1120 area plurality of runners 130A, which are additional struts that bow orbulge out radially when stent 1106 is expanded, as will be described ingreater detail with reference to FIGS. 11B and 11C. As shown in FIG.11A, runners 1130A are attached to the third full row of cells 1122Afrom proximal end 1102 so that, at least a portion of each runner isdisposed radially outward of leaflets 1110. In a second variation, shownin FIG. 11B, heart valve 1100B includes runners 1130B attached to thefirst full row of cells 1122B from proximal end 1102. In yet anothervariation, shown in FIG. 11C, heart valve 1100C includes runners 1130Cattached to the bottom-most struts 1120C so that they extend proximallyof the proximal end 1102 of stent 1106. It will be understood that thelongitudinal position of runners 1130 may be varied anywhere within theannulus section and/or transition section. Additionally, multiple rowsof runners may be disposed on stent 1106. Moreover, each cell in anannular row of cells need not include a runner. Thus, there may be morerunners in one annular row of cells than in another annular row ofcells.

FIG. 12 is a highly schematic cross-sectional view showing heart valve1200 having stent 1202, valve assembly 1204 including leaflets 1208 anda cuff 1222, and bowed runners 1230 supporting portions of cuff 1222. Asseen in FIG. 12, bowed runners 1230 extend radially outward from stent1202 to press cuff 1222 into the gaps between heart valve 1200 andnative valve annulus 250. Cuff 1222 may be capable of promoting tissuegrowth between heart valve 1200 and native valve annulus 250. Forexample, cuff 1222 may be innately capable or promoting tissue growthand/or may be treated with a biological or chemical agent to promotetissue growth, further enabling it to seal the heart valve within thenative valve annulus. When runners 1230 are functioning properly, heartvalve 1200 will be adequately sealed within native valve annulus 250 sothat blood flows through leaflets 1208 of valve assembly 1204, and sothat blood flow through any gaps formed between heart valve 1200 andnative valve annulus 250 is limited or reduced.

The preceding embodiments have illustrated a simplified arrangement inwhich a cuff is disposed on the abluminal surface of a stent andattached to runners such that the expansion of the runners pushes thecuff outwardly toward walls of the native valve annulus. Otherconfigurations of the cuff are also possible as illustrated below.

FIG. 13 is a schematic developed view of a portion of heart valve 1300including stent 1306 with cuff 1312 attached to same. For the sake ofclarity, leaflets of the valve assembly are not shown. Stent 1306includes a plurality of struts 1320 attached together to formdiamond-shaped cells 1322 as has been described above. Three commissurefeatures 1325 a, 1325 b, 1325 c are also shown attached to struts 1320.Runners 1330 are formed in each of cells 1322 in row R1 located directlybelow commissure features 1325.

Cuff 1312 is disposed on the luminal surface of stent 1306 (i.e., FIG.13 is a schematic illustration of the exterior of heart valve 1300).Cuff 1312 may he formed of a polymer, a fabric or tissue, such asbovine, porcine, ovine, equine, kangaroo, PTFE, UHMWPE, PET, Dacron,PVA, Polyurethane, silicone or combinations thereof. Cuff 1312 includesdiamond-shaped flaps 1350 for folding over certain cells 1322 in row R1that include runners 1330. Each flap 1350 may be attached to cuff 1312or formed integrally with cuff 1312 and may be folded at fold line F1from the luminal surface of stent 1306 to the abluminal, surface ofstent 1306 to cover runner 1330 as shown. A corresponding diamond-shapedsuture pattern C1 may attach a perimeter of flap 1350 to struts 1320forming row R1 of cells 1322 so that the bowing of runner 1330 pushesflap 1350 radially outward.

Panels 1352 formed of the same or different material than cuff 1322 mayhe coupled to all cells or to certain cells 1322 where folding isdifficult. Specifically, panels 1352 may be coupled to cuff 1312 and/orstruts 1320 of cells 1322 of row R1 located directly below commissurefeatures 1325, while flaps 1350 may be provided for all other cells 1322in row R1. Panels 1352 may be formed from segments of material that areinitially not attached to cuff 1312, and may be attached to cells 1322under commissure features 1325 using a diamond pattern of suturessimilar to that of pattern P1. For the sake of clarity, only one panel1352 is shown under the left-most commissure feature 1325 a and nopanels are shown under commissure features 1325 b, 1325 c so that theshape of cuff 1312 may he appreciated. It will be understood, however,that panels 1352 may be coupled to cells 1322 located under commissurefeatures 1325 b and 1325 c.

FIG. 14 is a schematic developed view of a portion of heart valve 1400including stent 1406 and cuff 1412 attached to the stent. Stent 1406includes struts 1420 forming cells 1422, commissure features 1425, andrunners 1430. Heart valve 1400 includes first flaps 1450 a that aresimilar to flaps 1350 of FIG. 13 described above. Heart valve 1400differs from heart valve 1300 in that second flaps 1450 b are alsoformed under commissure features 1425. Specifically, instead of panelsthat initially are separate from and later are attached to the cuff,cuff 1412 includes second flaps 1450 b that fold 180 degrees at foldline F2 and then attach to cell 1422 under commissure feature 1425 toform two layers of cuff sandwiching runner 1430. For the sake ofclarity, only one second flap 1450 b is shown under commissure feature1425 a. Thus, cuff 1412 may be integrally formed from a single piece ofmaterial, disposed, on the luminal surface of stent 1406 and includeflaps on the abluminal surface to cover runners 1430.

FIG. 15 is a similar developed view of a portion of heart valve 1500including stent 1506 with cuff 1512 attached thereto. Stent 1506includes struts 1520 forming cells 1522, commissure features 1525, andrunners 1530. Various methods of folding flaps over runners 1530 areshown. In each example, flap 1550 is folded to a position over cell 1522indicated by a diamond in broken lines. For example, flap 1550 a iscapable of folding diagonally downward to position 1550 a, while flaps1550 b fold diagonally upward toward position 1550 b′. Flap 1550 c mayfold straight down to position 1550 c and flap 1550 d may folddiagonally downward to position 1550 d′.

FIGS. 16A and 16B illustrate yet another example of cuff 1612 forcovering a plurality of runners 1630 using flaps 1650. FIG. 16Aillustrates the preassembled state in which cuff 1612 includes threeflaps 1650 a, 1650 b and 1650 c that will be horizontally folded overrunners 1630 and main portion 1660 of the cuff that covers six cells1622. Cuff 1612 may be formed of a single piece of material or may beformed as a composite cuff with multiple portions. For example, in FIG.16A, first flap 1650 a and second flap 1650 b may be formed of a firstpiece of material, main portion 1660 may be formed of a second piece ofmaterial and third flap 1650 c may be formed of a third piece ofmaterial. All three pieces may he sutured or otherwise coupled togetherto form a triple composite cuff.

As seen in the assembled state (FIG. 16B), first flap 1650 a and secondflap 1650 b have been folded horizontally so that first flap 1650 aextends to position 1650 a over first runner 1630 a, and second flap1650 b extends to position 1650 b over second runner 1630 b. Flap 1650 chas been folded horizontally (in a direction opposite to first flap 1650a and second flap 1650 b) to position 1650 c′ over third runner 1630 c.Flaps 1650 may then be sutured to their respective cells around theirperimeters.

In FIG. 17, heart valve 1700 includes scent 1706 and cuff 1712, as wellas runners 1730 in row R1 of cells 1722. Instead of folding flaps asdescribed above, individual panels 1750 are sutured around theirperimeter to each cell 1722 in row R1 as shown. Panels 1750 may beformed of the same material as cuff 1712, or from a different material.Because runners 1730 bow outwardly, panels 1750 may be slightly largerthan the underlying cells 1722, such as first panel 1750 a, so as to notimpede the outward bowing. Additionally, panels 1750 may be formed witha specific fiber orientation, compliance, thickness or the like to allowfor the bowing. Pockets formed between cuff 1712 and panels 1750 may befilled with a liquid, a gel, a powder or other media to help support theoutward bulging of the panels and thereby help mitigate paravalvularleakage. One example of the filler media may be a solution of polyvinylalcohol (PVA). As cuff 1712 and panels 1750 contact blood upon theimplantation of prosthetic heart valve 1700, the filler media may swellin size, increasing the size and specifically the diameter of thepockets between the cuff and the panels. The enlarged pockets thus fillthe gaps between the native valve annulus and the prosthetic heartvalve, minimizing or preventing paravalvular leakage.

FIG. 18 is a schematic developed view of a portion of heart valve 1800including stoat 1806 and cuff 1812 attached to the stent. Stent 1806includes struts 1820 forming cells 1822, commissure features 1825, andrunners 1830. In FIG. 15, runners 1330 were formed in each of cells 1322in row R1 located directly below commissure features 1325. In theinstant example, runners 1830 are provided in each of the cells in rowR2 located in the second full row below commissure features 1825. Flaps1850 a and 1850 b fold vertically downward to positions 1850 a′ and 1850b′, respectively, sandwiching certain runners 1630 between cuff 1612 andthe flaps. Other runners 1830 may be covered with individual panels (notshown) as described above with reference to FIG. 17.

FIG. 19 illustrates another variation in which heart valve 1900 includesflaps 1950 a-f which are arranged to fold over runners 1930 in row R2.Flaps 1950 a-f may be unitarily formed with cuff 1912 and cut at certainedges depending on their intended position to create individualdiamond-shaped flaps. Flaps 1950 a-f may be folded either diagonally orvertically downward to positions 1950 a′-f′, respectively. In anothervariation of folding flaps over the runners in second row R2, FIG. 20illustrates heart valve 2000 having runners 2030 and flaps 2050 a-f thatare foldable directly upward to the abluminal surface onto positions2050 a′-f′ as shown. In a further variation, of the FIG. 20 embodiment,individual panels as shown in FIG. 17 may be disposed over each ofrunners 2030 in second row R2. Such panels may be enlarged or chosenbased on specific properties as discussed above with reference to FIG.17.

In FIG. 21, heart valve 2100 includes stent 2106 and attached cuff 2112.Stent 2106 includes a plurality of cells 2122 and runners 2130 in secondrow R2 of the cells. Cuff 2112 is attached to the luminal surface ofstout 2106. Instead of individual panels or folded flaps, heart valve2100 includes a unitary sheet of material 2150 coupled to the abluminalsurface of stent 2106. Sheet 2150 may be sized to extend over all cells2122 in second row R2 and may be attached to cuff 2112 using suturepattern s21. Suture pattern S21 extends around the perimeter of sheet2150 with the exception of edges E1, which may be left unattached tocuff 2122. Blood flowing in a retrograde direction when heart valve 2100is implanted in a patient may enter into a pocket P21 formed betweensheet 2150 and cuff 2112 at edges E21 and causes the pocket to expand.In one variation of this embodiment, cuff 2112 and sheet 2150 may beunitarily formed such that a single piece material is folded from theluminal surface over the bottom of the stent and forms a second layer onthe abluminal surface of the stent. In one example, such a fold ortransition may be made distal to the runners.

FIG. 22A is a schematic developed view of heart valve 2200 includingscent 2206 and attached cuff 2212A. Stent 2206 includes struts 2220forming cells 2222, commissure features 2225, and runners 2230. Threerows of cells, R1, R2, R3 are shown below commissure feature 2225. Inthis example, runners 2230 are disposed in row R3 of incomplete cellsdefined at the proximal end of stent 2206, and are attached to thebottom-most struts 2220 of stent 2206 in a manner similar to the stentdescribed in connection with the embodiment of FIG. 11G. Individualpanels 2250 may be sutured over each portion of a cell having a runner.In a slight variation, shown in FIG. 22B, cuff 2212B may be disposed onthe luminal surface of a stent (not shown) and include a plurality oftriangular flaps 2260 that may be folded upwardly at fold line P22 andextend over the runners on the abluminal surface of the stent. Thus,flaps 2260 may take the place of individual panels 2250 from FIG. 22A.

In FIG. 23, heart valve 2300 includes stent 2306 and attached cuff 2312.Stent 2306 includes a plurality of cells 2322 arranged in three rows,R1, R2, R3 below commissure feature 2325. Runners 2330 are disposed inrow R3 of incomplete cells 2322 at the proximal end of the stent. Cuff2312 is attached to the luminal surface of stent 2306. Heart valve 2300further includes a unitary sheet of material 2350 coupled to theabluminal surface of stent 2306 so as to overlie runners 2330. Sheet2350 may be sized to extend over all incomplete cells 2322 in row R3 andmay be attached to cuff 2312 using a stitch pattern 323 around theperimeter of sheet 2350. Thus, cuff 2312 and sheet 2350 may form acontinuous pocket P23, which functions similarly to individual pocketsP21 of FIG. 21 described above.

FIG. 24 illustrates heart valve 2400 including stent 2406 and attachedcuff 2412. Stent 2406 includes a plurality of cells 2422 arranged inthree rows, R1, R2, R3 below commissure feature 2425. Runners 2430 aredisposed in third row R3 of incomplete cells 2422 at the proximal end ofthe stent. Instead of a unitary sheet of material or individual panels,cuff 2412 includes upper portion 2450 and lower portion 2452 and fold,line F24 separating the two portions. Fold line F24 is disposed alongthe tops of the incomplete cells in third row R3. Lower portion 2452 isdivided into individual, substantially rectangular segments 2454 upperportion 2450 is attached to the luminal surface of stent 2406. At foldline F24, rectangular segments 2454 may be folded from the luminalsurface to the abluminal surface of stent 2406, each segment passingthrough the center of cell 2412. Segments 2434 of lower portion 2452 maythen be stitched to adjacent segments and to runners 2430. To aid insecuring segments 2454 of lower portion 2452, each runner 2430 mayinclude a horseshoe 2460 at its free end and segments 2454 may besutured to horseshoes 2460, which may prevent lower portion 2452 fromriding up runner 2430 during assembly or use. In some variations,eyelets or other similar features may be disposed at the free ends ofthe runners. Thus, a portion of cuff 2412 is disposed on the luminalsurface of stent 2406 and a second portion of cuff 2412 is disposed overrunners 2430 and on the abluminal surface of stent 2406.

While the devices disclosed herein have been described for use inconnection with heart valve stents having a particular shape, the stentcould have different shapes, such as a flared or conical annulussection, a less bulbous aortic section, and the like, as well as adifferently shaped transition section. Additionally, though the runnersand cuffs have been described in connection with expandabletranscatheter aortic valve replacement, they may also be used inconnection with other expandable cardiac valves, as well as withsurgical valves, sutureless valves and other devices in which it isdesirable to create a seal between the periphery of the device and theadjacent body tissue.

Moreover, although the disclosures herein have been described withreference to particular embodiments, it is to be understood that theseembodiments are merely illustrative of the principles and applicationsof the present disclosure. It is therefore to be understood thatnumerous modifications may be made to the illustrative embodiments andthat other arrangements may be devised without departing from the spiritand scope or the present claims.

In some embodiments, a prosthetic heart valve for replacing a nativevalve includes a stent extending between a proximal end and a distal endand including a plurality of struts forming cells, the stent having acollapsed condition and an expanded condition. At least one runner iscoupled to a cell, the at least one runner being configured totransition from a first configuration to a second configuration when thestent moves from the collapsed condition to the expanded condition, theat least one runner projecting radially outwardly from the cell in thesecond configuration. A valve assembly is disposed within the stent, thevalve assembly including a plurality of leaflets, a cuff at leastpartially disposed on a luminal surface of the stent and a coveringmaterial disposed on an abluminal surface of the stent and covering theat least one runner in the second configuration.

In some examples, the at least one runner is substantially linear in thefirst configuration, and/or the at least, one runner is bowed in thesecond configuration, and/or the cuff includes at least one flapconfigured to fold from the luminal surface to the abluminal surface ofthe stent to form the covering material, and/or the flap folds over aselected strut from the distal end toward the proximal end of the stent,and/or the flap folds over a selected, strut from the proximal endtoward the distal end of the stent, and/or the flap folds diagonallyover a selected strut, and/or the at least one runner comprises multiplerunners and the covering material includes a plurality of individualpanels, each of the plurality of individual panels being disposed overone of the multiple runners, and/or the covering material includes atleast one diamond-shaped panel disposed over at least one cell, and atleast one flap integrally formed with the cuff and configured to foldfrom the luminal surface to the abluminal surface of the stent, and/orthe stent further includes commissure features and the at least onerunner coupled to selected cells in a first row of the cells proximal ofthe commissure features, and/or the stent further includes commissurefeatures and the at least one runner coupled to selected cells in asecond row of the cells proximal of the commissure features, and/or aplurality of runners coupled to proximal-most struts of the stent andextending proximally of the proximal end of the stent, and/or each ofthe plurality of runners extends from a first end joined to a strut to afree end, and/or each free end has a horseshoe shape, the coveringmaterial being sutured to the horseshoe shape, and/or the coveringmaterial includes a sheet of material circumferentially disposed on theabluminal surface of the stent so as to extend over a row of cells.

In some embodiments, a prosthetic heart valve for replacing a nativevalve includes a stunt extending between a proximal end and a distal endand including a plurality of struts forming cells and a plurality ofrunners, the stent having a collapsed condition and an expandedcondition, the struts defining a first diameter and the runners defininga second diameter, the second diameter being greater than the firstdiameter. A valve assembly is disposed within the stent, the valveassembly including a plurality of leaflets and a cuff at least partiallydisposed on a luminal surface of the stent and partially disposed on anabluminal surface of the stent to cover the runner.

In some examples, the stent includes a plurality of commissure featuresand the cuff includes an upper portion and a lower portion, the upperportion being disposed on the luminal surface of the stent and coupledto the commissure features and the lower portion being disposed on theabluminal surface of the stent so as to cover the plurality of runners,and/or the lower portion is divided into individual segments capable ofpassing through the cells from the luminal surface to the abluminalsurface, and/or the cuff transitions from the luminal surface to theabluminal surface distal to the plurality of runners, and/or each of theindividual segments is coupled to an adjacent segment and a runner.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

1. A prosthetic heart valve for replacing a native valve, comprising; astent extending between a proximal end and a distal end and including aplurality of struts forming cells, the stent having a collapsedcondition and an expanded condition; at least one runner coupled to acell, the at least one runner being configured to transition from afirst configuration to a second configuration when the stent moves fromthe collapsed condition to the expanded condition, the at least onerunner projecting radially outwardly from the cell in the secondconfiguration; and a valve assembly disposed within the stent, the valveassembly including a plurality of leaflets, a cuff at least partiallydisposed on a luminal surface of the stent, and a covering materialdisposed on an abluminal surface of the stent and covering the at leastone runner in the second configuration.
 2. The prosthetic heart valve ofclaim 1, wherein the at least one runner is substantially linear in thefirst configuration.
 3. The prosthetic heart valve of claim 1, whereinthe at least one runner is bowed or curved in the second configuration.4. The prosthetic heart valve of claim 1, wherein the cuff includes atleast one flap configured to fold from the luminal surface to theabluminal surface of the stent to form the covering material.
 5. Theprosthetic heart valve of claim 4, wherein the flap folds over aselected strut from the distal end toward the proximal end of the stent.6. The prosthetic heart valve of claim 4, wherein the flap folds over aselected strut from the proximal end toward the distal end of the stent.7. The prosthetic heart valve of claim 4, wherein the flap foldsdiagonally over a selected strut.
 8. The prosthetic heart valve of claim1, wherein the at least one runner comprises multiple runners andwherein the covering material includes a plurality of individual panels,each of the plurality of individual panels being disposed over one ofthe multiple runners.
 9. The prosthetic heart valve of claim 1, whereinthe covering material includes at least one diamond-shaped paneldisposed over at least one cell, the covering material further includingat least one flap integrally formed with the cuff and configured to foldfrom he luminal surface to the abluminal surface of the stent.
 10. Theprosthetic heart valve of claim 1, wherein the stent further includescommissure features, and wherein the at least one runner is coupled toselected cells in a first row of cells proximal of the commissurefeatures.
 11. The prosthetic heart valve of claim 1, wherein the stentfurther includes commissure features, and wherein the at least onerunner is coupled to selected cells in a second row of cells proximal ofthe commissure features.
 12. The prosthetic heart valve of claim 1,further comprising a plurality of runners coupled to proximal-moststruts of the stent and extending proximally of the proximal end of thestent.
 13. The prosthetic heart valve of claim 12, wherein each of theplurality of runners extends from a first end joined to a strut to afree end.
 14. The prosthetic heart valve of claim 13, wherein each freeend has a horseshoe shape, the covering material being sutured to thehorseshoe shape.
 15. The prosthetic heart valve of claim 1, wherein thecovering material includes a sheet of material circumferentiallydisposed on the abluminal surface of the stent so as to extend over arow of cells.
 16. A prosthetic heart valve for replacing a native valve,comprising: a stent extending between a proximal end and a distal endand including a plurality of struts forming cells and a plurality ofrunners, the stent having a collapsed condition and an expandedcondition, the struts defining a first diameter and the runners defininga second diameter, the second diameter being greater than the firstdiameter; and a valve assembly disposed within the stent, the valveassembly including a plurality of leaflets and a cuff at least partiallydisposed on a luminal surface of the stent and partially disposed on anabluminal surface of the stent to cover the runners.
 17. The prostheticheart valve of claim 16, wherein the stent includes a plurality ofcommissure features and the cuff includes an upper portion and a lowerportion, the upper portion being disposed on the luminal surface of thestent and coupled to the commissure features and the lower portion beingdisposed on the abluminal surface of the stent so as to cover theplurality of runners.
 18. The prosthetic heart valve of claim 17,wherein the lower portion is divided into individual segments capable ofpassing through the cells from the luminal surface to the abluminalsurface.
 19. The prosthetic heart valve of claim 18, wherein the cufftransitions from the luminal surface to the abluminal surface distal tothe plurality of runners.
 20. The prosthetic heart valve of claim 18,wherein each of the individual segments is coupled to an adjacentsegment and a runner.